Aortic DissectionARISE IIINCT06827990

GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections

A study testing GORE® Ascending Stent Graft (ASG device) in people with Aortic Dissection, run by W.L.Gore & Associates at 22 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Dissection
What is being tested?: GORE® Ascending Stent Graft (ASG device)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 22 sitesUnited States
Study dates: 22 Sep 2025to 1 Sep 2031
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject is/has:
De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device.
Primarily intended to be treated by placement of the ASG device in the ascending aorta. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.
Anatomic compatibility of the ascending aorta required for implanting the ASG device:
Proximal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm distal to the most distal coronary artery ostium.
Total aortic diameter between 27mm - 48mm iii. Landing zone cannot be heavily calcified or thrombosed. b) Distal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium.

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Adequate aortic length
The Aortic Treatment Team (as defined by the protocol) attest endovascular repair is in the best interest of the patient AND considers the patient to be high-risk for open surgical repair by meeting at least one of the following criteria:
≥80 years of age
Body mass index (BMI) ≥ 35 kg/m2
History of Respiratory Insufficiency (defined by home O2 usage, exertional dyspnea, imaging evidence of COPD, previous evidence of compromised pulmonary function tests (PFT) on spirometry or other factors as determined by the Investigator)
Prior Cardiac Surgery
Hostile Chest (VARC-2 Definition)
Clinical Frailty Scale 3-7
Clinical malperfusion (head, gut, lower extremity)
Transfusion is not possible (e.g., Jehovah's Witness)
Renal Dialysis prior to aortic dissection
Chronic renal insufficiency (eGFR<60 without dialysis or other documented history of chronic kidney disease prior to dissection)
Age ≥18 years at time of informed consent signature.
Adequate vascular access via transfemoral or retroperitoneal approach.
Informed Consent Form (ICF) signed by the subject or legally authorized representative.
Agrees to comply with protocol requirements, including imaging and 5-year follow-up, as the subject's condition allows.
The subject is/has:
De novo Type A aortic dissection (≤90 days from symptom onset until first study procedure) compatible with the treatment requirements of the ASG device alone or the ASG device in combination with the TBE device in the Zone 0 position.
Primarily intended to be treated by placement of the ASG device in the ascending aorta or ASG device in combination with the TBE device in the ascending aorta and aortic arch. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.
Anatomic requirements for intended treatment with the ASG device alone or in combination with the TBE device.
Anatomic compatibility required for implanting the ASG device (Intended treatment with ASG device alone) i. Proximal Aortic Landing Zone:
Primary entry tear must be in the ascending aorta and ≥ 2 cm distal to the most distal coronary artery ostium.
Total aortic diameter between 27mm - 48mm.
Landing zone cannot be heavily calcified or thrombosed. ii. Distal Aortic Landing Zone:
Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium.
Adequate aortic length
Anatomic compatibility required for implanting the ASG device (Intended treatment with ASG device and TBE device) i. Proximal Aortic Landing Zone:
Primary entry tear must be identified in Zone 0-5.
Landing zone is native aorta.
Primary entry tear location is ≥2cm distal to the most distal coronary artery ostium.
Proximal landing zone must be ≥2cm in the ascending aorta.
Landing zone cannot be heavily calcified or thrombosed.
Total aortic landing zone diameter 27mm - 48mm. ii. Branch Vessel Landing Zone:
Length of ≥2.5 cm proximal to first major branch vessel.
Target branch vessel inner diameters of 11-18 mm.
Target branch vessel landing zone must be in native vessel that cannot be heavily calcified or thrombosed.
The distal 15mm landing zone cannot be dissected.
The Aortic Treatment Team (as defined by the protocol) attest endovascular repair is in the best interest of the patient AND considers the patient to be high-risk for open surgical repair by meeting at least one of the following criteria:
≥80 years of age
BMI ≥ 35 kg/m2
History of Respiratory Insufficiency (defined by home O2 usage, exertional dyspnea, imaging evidence of COPD, previous evidence of compromised PFTs on spirometry or other factors as determined by the Investigator)
Prior Cardiac Surgery
Hostile Chest (VARC-2 Definition)
Clinical Frailty Scale 3-9
Clinical malperfusion (head, gut, lower extremity)
Transfusion is not possible (e.g., Jehovah's Witness)
Renal Dialysis prior to aortic dissection
Chronic renal insufficiency (eGFR<60 without dialysis or other documented history of chronic kidney disease prior to dissection)
Age ≥18 years at time of informed consent signature.
Adequate vascular access via transfemoral or retroperitoneal approach.
Informed Consent Form (ICF) signed by the subject or legally authorized representative.
Agrees to comply with protocol requirements, including imaging and 5-year follow-up, as the subject's condition allows.

Who cannot join

The subject is/has:
Mechanical heart valve in the aortic position.
Aortic insufficiency grade 3 or greater confirmed during TEE pre-implant.
Indwelling intravascular device that would interfere with or result in contact with planned repair (e.g., contiguous arch graft, LVAD, TAVR device in continuity with aortic tear).
Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome).
Participation in investigational drug or medical device study within one year of enrollment unless approved by the Sponsor.

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Known history of drug abuse within one year of treatment which would affect the ability to obtain follow-up.
Pregnant at time of procedure.
Active infected aorta, mycotic aneurysm.
Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).
Life expectancy <12 months due to presence of another comorbid condition.
Known sensitivities or allergies to the device materials (Previous instance of Heparin Induced Thrombocytopenia type 2 [HIT-2], known hypersensitivity to heparin, or a history of a hypercoagulability disorder and/or state should be considered exclusion if treatment plan includes implant of a TBE device).
Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
Coronary malperfusion.
Catastrophic neurological complications in the 30 days prior to the dissection diagnosis (e.g., progressively worsening symptoms, coma, Glasgow Coma Scale <=8).
Aortic fistula.
In circulatory shock (e.g., systolic blood pressure <80 mmHg without inotropes, base deficit > -10 mmol/L or -10 mEq/L) at any time prior to the initiation of the index endovascular procedure.
In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at any time prior to the initiation of the index endovascular procedure.
Clinical or radiographic signs of bowel infarction, gastrointestinal hemorrhage, or bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and/or acidosis) at any time prior to the initiation of the index endovascular procedure.
The subject is/has:
Mechanical heart valve in the aortic position.
Pregnant at time of procedure.
Active infected aorta, mycotic aneurysm.
Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).
Known sensitivities or allergies to the device materials (Previous instance of Heparin Induced Thrombocytopenia type 2 [HIT-2], known hypersensitivity to heparin, or a history of a hypercoagulability disorder and/or state should be considered exclusion if treatment plan includes implant of a TBE device).
Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern Medicine
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43214
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32608
Corewell Health System
Grand Rapids, Michigan, 49503
Hackensack Medical Center
Hackensack, New Jersey, 07601
The Methodist Hospital Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Southern California
Los Angeles, California, 90033
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
WVU Medicine
Morgantown, West Virginia, 26506
The Stanford Hospital
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 18104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Baylor Research Institute
Plano, Texas, 75093
Washington University School of Medicine - St. Louis
St Louis, Missouri, 63110
Westchester Medical Center
Westchester, New York, 10595

Other trials in United States

About this study

Official title: Evaluation of the GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections

To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.

Read the detailed description

This pivotal investigation is a prospective, multicenter, non-randomized, single-arm study to evaluate the safety and effectiveness of the ASG device for the treatment of de novo Type A aortic dissections in patients considered to be high-risk for open surgical repair.

Conditions: Aortic Dissection
Being tested: GORE® Ascending Stent Graft (ASG device)
Medical subject headings: Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GORE® Ascending Stent Graft (ASG device)Device
Endovascular aortic repair of the ascending aorta

Study groups in NCT06827990
Study group	Role	What they receive
Primary	Experimental	A hypothesis driven analysis of the safety and effectiveness of the GORE® Ascending Stent Graft (ASG) device alone in the ascending aorta. Dissection chronicity in the primary arm must be 30 days or less from symptom onset to index endovascular procedure. Receives: Device: GORE® Ascending Stent Graft (ASG device)
Secondary	Experimental	Descriptive analysis of use of the ASG device in patients who are not eligible for treatment in the primary arm. Dissection chronicity up to 90 days from symptom onset until the first study procedure is allowed in the secondary arm. Receives: Device: GORE® Ascending Stent Graft (ASG device)

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Safety Endpoint
Composite of the following events:
Death ≤30 days of the index endovascular procedure, or during initial hospitalization, whichever is later
Disabling Stroke ≤30 days following the index endovascular procedure
Measured: 30 Days
Primary Effectiveness Endpoint
Clinical Success, a composite of:
Assisted Technical Success (at end of index endovascular procedure)
Absence of the following (cumulative through 30-days, except as specified):
Aortic rupture
Death ≤30days of the index endovascular procedure, or during initial hospitalization, whichever is later
Study Device Reintervention
Conversion to open surgical repair
Measured: 30 Days

Secondary outcomes (1)

Secondary Endpoint
Procedural Success
Treatment Success
Primary Technical Success (Unassisted)
SF-36® Physical Component Summary measured at one year follow-up
Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 20251 Sep 2031

First posted14 Feb 2025
Study start22 Sep 2025
Primary completion1 Sep 2030 (estimated)
Study completion1 Sep 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic DissectionStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06827990
Sponsor's protocol ID: ASG 24-02
Acronym: ARISE III
Status last verified: Oct 2026
First submitted: 10 Feb 2025
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Individual participant data will not be available to other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm

All Aortic Dissection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
ClinicalTrials.gov ID: NCT06827990
Acronym / sponsor ID: ARISE III / ASG 24-02
Conditions: Aortic Dissection
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 112 participants (estimated)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: 22 Sep 2025 (actual)
Primary completion: 1 Sep 2030 (estimated)
Study completion: 1 Sep 2031 (estimated)
First posted: 14 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Primary	Experimental	Device: GORE® Ascending Stent Graft (ASG device)A hypothesis driven analysis of the safety and effectiveness of the GORE® Ascending Stent Graft (ASG) device alone in the ascending aorta. Dissection chronicity in the primary arm must be 30 days or less from symptom onset to index endovascular procedure.
Secondary	Experimental	Device: GORE® Ascending Stent Graft (ASG device)Descriptive analysis of use of the ASG device in patients who are not eligible for treatment in the primary arm. Dissection chronicity up to 90 days from symptom onset until the first study procedure is allowed in the secondary arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (61 listed)

De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device.
Primarily intended to be treated by placement of the ASG device in the ascending aorta. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.
Anatomic compatibility of the ascending aorta required for implanting the ASG device:
The Aortic Treatment Team (as defined by the protocol) attest endovascular repair is in the best interest of the patient AND considers the patient to be high-risk for open surgical repair by meeting at least one of the following criteria:
Age ≥18 years at time of informed consent signature.

Key exclusion criteria (26 listed)

Mechanical heart valve in the aortic position.
Aortic insufficiency grade 3 or greater confirmed during TEE pre-implant.
Indwelling intravascular device that would interfere with or result in contact with planned repair (e.g., contiguous arch graft, LVAD, TAVR device in continuity with aortic tear).
Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome).
Participation in investigational drug or medical device study within one year of enrollment unless approved by the Sponsor.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GORE® Ascending Stent Graft (ASG device)Endovascular aortic repair of the ascending aorta	Device	Primary, Secondary

Primary outcome

Primary Safety Endpoint
Time frame: 30 Days
Composite of the following events: Death ≤30 days of the index endovascular procedure, or during initial hospitalization, whichever is later Disabling Stroke ≤30 days following the index endovascular procedure
Primary Effectiveness Endpoint
Time frame: 30 Days
Clinical Success, a composite of: Assisted Technical Success (at end of index endovascular procedure) Absence of the following (cumulative through 30-days, except as specified): Aortic rupture Death ≤30days of the index endovascular procedure, or during initial hospitalization, whichever is later Study Device Reintervention Conversion to open surgical repair

1 secondary outcome

Secondary Endpoint
Time frame: 1 Year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.

Related trials for Aortic Dissection

Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric Roselli, MD principal investigator

The Cleveland Clinic

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GORE® Ascending Stent Graft (ASG device) in people with Aortic Dissection, run by W.L.Gore & Associates at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 61 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06827990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.